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Quizartinib and High-dose Ara-C Plus Mitoxantrone in Relapsed/Refractory AML With FLT3-ITD

NCT03989713 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2022-09-15

No results posted yet for this study

Summary

In this multicenter, upfront randomized phase II trial, all patients receive quizartinib in combination with HAM (high-dose cytarabine, mitoxantrone) during salvage therapy. Efficacy is assessed by comparison to historical controls based on the matched threshold crossing approach. During consolidation therapy (chemotherapy as well as allo-HCT) patients receive either prophylactic quizartinib therapy or MRD-triggered preemptive continuation therapy with quizartinib according to up-front randomization.

Conditions

  • AML According to WHO 2016 Classification (Except Acute Promyelocytic Leukemia) AND (Refractory to Induction Therapy OR Relapsed After First Line Treatment)

Interventions

DRUG

MRD-triggered arm

1. Salvage therapy: Quizartinib: 40mg, p.o., Days: 4 - 21 Cytarabine: 18-60yrs: 3g/m² bid / \>-60yrs: 1g/m² bid, i.v. 3h i.v. 3h, Days: 1,2,3; Mitoxantrone: 10mg, i.v. 30min: Days: 2,3; 2. Consolidation therapy: Cytarabine: 18-60yrs: 3g/m² bid, i.v. 3h / \>-60yrs: 1g/m² bid, i.v. 3h, Days: 1,2,3; Mitoxantrone: 10mg, i.v. 30min, Days: 2,3 3. Observation therapy: No treatment

DRUG

Prophylactic Arm

1. Salvage therapy: Quizartinib: 40mg, p.o., Days: 4 - 21 Cytarabine: 18-60yrs: 3g/m² bid / \>-60yrs: 1g/m² bid, i.v. 3h i.v. 3h, Days: 1,2,3; Mitoxantrone: 10mg, i.v. 30min: Days: 2,3; 2. Consolidation therapy: Quizartinib: 40mg, p.o., Days: 4 - 21 Cytarabine: 18-60yrs: 3g/m² bid, i.v. 3h / \>-60yrs: 1g/m² bid, i.v. 3h, Days: 1,2,3; Mitoxantrone: 10mg, i.v. 30min, Days: 2,3; 3. Maintenance therapy: Quizartinib: Cycle 1, Days 1-15: 40mg, p.o. and Day 16-28: 60mg, p.o.

Sponsors & Collaborators

  • Prof. Dr. Richard F Schlenk

    lead OTHER

Principal Investigators

  • Richard F. Schlenk, Prof. Dr. · University Hospital Heidelberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-17
Primary Completion
2022-09-11
Completion
2022-09-11

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03989713 on ClinicalTrials.gov